Recalls / —
—#126819
Product
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
- FDA product code
- LKK — Pump, Infusion, Implanted, Programmable
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P860004S056
- Affected lot / code info
- Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014.
Why it was recalled
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
Root cause (FDA determination)
Process control
Action the firm took
Medtronic sent a "Medical Device Removal" letter dated April 2014 hand delivered, e-mail or faxed to affected customers. The letter described the problem and the product affected by the recall. The letter also contained the Action Required, Additional Information (Contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm Central Time) and requested consignees to complete and fax or e-mail the "Medical Device Removal Reply Form".
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
Timeline
- Recall initiated
- 2014-04-04
- Posted by FDA
- 2014-05-08
- Terminated
- 2014-11-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126819. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.